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The SILVA Study: Survival in an International Phase III Prospective Randomized LD Small Cell Lung Cancer Vaccination Study With Adjuvant BEC2 and BCG


Phase 3
18 Years
N/A
Not Enrolling
Both
Carcinoma, Small Cell Lung

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Trial Information

The SILVA Study: Survival in an International Phase III Prospective Randomized LD Small Cell Lung Cancer Vaccination Study With Adjuvant BEC2 and BCG


Inclusion Criteria:



- Histo-cytologically proven SCLC

- Limited disease at diagnosis

- Age greater than or equal to 18

- Patients with a clinical response of CR or PR to first line combined modality
therapy

- KPS greater than or equal to 60

- Adequate bone marrow, liver and heart functions

- Written informed Consent

Exclusion Criteria:

- Prior surgical treatment for SCLC

- History of tuberculosis

- NCIC CTG grade 3 local skin toxicity reaction (ulceration) to > IU PPD test > 5 IU

- HIV positive

- Splenectomy or spleen radiation therapy in medical history

- Prior therapy to proteins of murine origin

- Any second line therapy for SCLC

- Investigational agent or immune therapy within 4 weeks prior to study randomization

- Severe active infections

- Active infections requiring systemic antibiotics, antiviral, or antifungal treatments

- Serious unstable chronic illness

- The use of systemic anti-histamines, NSAID or systemic corticosteroids

- Any previous malignancy except adequately treated CIS of the cervix or non melanoma
skin cancer or if previous malignancy was more than 5 years prior and there are no
signs of recurrence

- Pregnancy or breast feeding or absence of adequate contraception for fertile patients

- Any psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule; those conditions
should be assessed with the patient before randomization in the trial.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

6 monthly basis until progression of disease

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

SILVA EORTC 08971

NCT ID:

NCT00037713

Start Date:

September 1998

Completion Date:

October 2002

Related Keywords:

  • Carcinoma, Small Cell Lung
  • LD Small Cell Lung Cancer
  • BEC2, vaccine
  • adjuvant, monoclonal antibody
  • LD Small Cell Lung Cancer (VA Classification, Zelen, 1973)
  • Carcinoma
  • Lung Neoplasms
  • Small Cell Lung Carcinoma
  • Carcinoma, Small Cell

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